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Session 1B: Round-table: Challenges in Pediatric Clinical Research

Day & Time:
October 21, 2:00PM - 3:50PM


Session 1B: Round-table: Challenges in Pediatric Clinical Research

José Luiz Egydio Setúbal
President of the José Luiz Egydio Setúbal Foundation
Hospital Infantil Sabara, Brazil

Charles Schmidt, MD
Head Scientific Medical Advisory Board, Prof., Santa Casa Medical School
Esterm Medical CRO, Brazil

In the U.S., BPCA and PREA laws regulate the labeling and encourage pediatric studies in this age group, improving new pediatric information. In June 2012, the Senate and House of Representatives of the United States of America enacted the’’ Food and Drug Administration Safety and Innovation Act’’. With this amendment the rules for pediatric drug labeling must comply with the standards established BPCA and PREA, that became permanent and mandatory. This document would clarify the Secretary’s authority to award exclusivity for studies conducted pursuant to a written request, including a conforming change for biological products. Furthermore, would require the Secretary, within three years of enactment, to make public the medical, statistical, and clinical pharmacology reviews of written requests made between 2002 and 2007 that resulted in a labeling change. Besides that, would reauthorize the Pediatric Advisory Committee and the Program for Pediatric Study of Drugs and will require a report every five years evaluating the effectiveness of BPCA and PREA. For this reason we need to be more active in increasing the awareness of development Pediatric Clinical Trials in our region too. Latin American countries are in process of revalidating their Pediatric products and also dedicated for more innovation in this field. This session will discuss the challenges and opportunities to implement Pediatric studies in our countries.

Presentation(s) & Speaker(s):
Challenges for Clinical Research in Pediatric and Neonatal Patients in Korea
Min Soo Park, MD,PhD
Director, Clinical Trials Center, Severance Hospital
Yonsei University College of Medicine, Korea, Republic of

Pediatric Drug Development: Where we Have Been and Where we are Going
Barry Mangum, MD
Director, Clinical Pharmacology
Duke University Medical Center, United States

Experience of a Pediatric Oncology Clinical Research Center in Brazil
Sergio Petrilli, MD
Federal University of São Paulo, Brazil